1. Home
  2. Labeler Index
  3. Simpex Pharma Pvt. Ltd
  4. 76457-002
  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. CONSULT YOUR DOCTOR IF YOU HAVE
    8. CONSULT YOUR DOCTOR IF YOU ARE TAKING SEDATIVES OR TRANQUILIZERS
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OR REACH OF CHILDREN.
    11. WHEN USING THIS PRODUCT
    12. DIRECTIONS:
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENT
    15. PACKAGE LABELING:

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Simpex Pharma Pvt. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each Tablet)



Diphenhydramine hydrochloride 25 mg


Purpose



Antihistamine


Uses



temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

  • runny nose
  • sneezing
  • Itchy watery eyes
  • Itching of the nose or throat.

Warnings




Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.

Consult Your Doctor If You Have



  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.

Consult Your Doctor If You Are Taking Sedatives Or Tranquilizers



  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur especially in children.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Or Reach Of Children.



In case of overdose, get medical help or contact a poison control center right away.


When Using This Product



  • marked drowsiness may occur
  • avoid alcoholic drinks.

Directions:



  • take every 4 to 6 hours
  • do not take more than 6 does in 24 hours
  • Adult and children 12 years of age and over - 1 to 2 tablet
  • Children 6 to 12 years of age - 1 tablet
  • Children 6 years of age - do not use this product in children under 6 years

Other Information



  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15°-30° (59°-86° F)
  • protect from light and moisture

Inactive Ingredient



carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,


Package Labeling:



Label2 - Label2

Label2 - Label2


* Please review the disclaimer below.